GORE TAG Conformable Thoracic Stent Graft TGMR313120Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00733132646791), received between Feb 26, 2020 and Oct 29, 2025 — classified as 2 deaths, 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

6 other recalls cover devices cleared under the same FDA submission (P040043); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE REPORTED THE FOLLOWING: ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TO TREAT A THORACIC ANEURYSM. REPORTEDLY THE PATIENT HAD A PREVIOUS ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH SEVERAL MEDTRONIC AORTO-UNI-ILIAC DEVICES. THERE WAS NO RIGHT SIDED ACCESS DUE TO A PREVIOUS FEM-FEM BYPASS PROCEDURE. THE PHYSICIAN PERFORMED A LEFT SIDE RETROPERITONEAL CUTDOWN FOR ACCESS. ACCESS WAS PRE-DILATED WITH A 16FR AND A 18FR DILATOR BEFORE ADVANCING A 20FR SHEATH FOR THE PROCEDURE. IT WAS REPORTED THAT THERE WAS MILD RESISTANCE WHILE ADVANCING THE DELIVERY CATHETER OF THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. AFTER THE PRIMARY DEPLOYMENT WAS PERFORMED, THE PHYSICIAN NOTICED THAT 2CM DISTAL OF THE PROXIMAL END OF THE GRAFT WAS COMPRESSED. FULL DEPLOYMENT WAS COMPLETED, AND THE COMPRESSION REMAINED. DURING THE FINAL STAGE OF DEPLOYMENT, THE GRAFT IN-FOLDED ON ITSELF (1800-E:-IMPLANTABLE DEVICE EVENTS POST DEPLOYMENT - OTHER/UNKNOWN). THE PHYSICIAN REMOVED THE DELIVERY CATHETER AND BALLOONED THE GRAFT AND THEN RELINED WITH TWO ADDITIONAL GORE® TAG® CONFORMABLE

  Patient problems: Aneurysm

  MAUDE report 23420503 ↗
• MalfunctionApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN INFRARENAL ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT UPON INITIATING PRIMARY DEPLOYMENT AND PULLING BACK THE PRIMARY DEPLOYMENT HANDLE OF A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG AC), THE DEVICE DID NOT DEPLOY TO THE ¿INTERMEDIATE¿ (50%) DIAMETER; THE DEPLOYMENT LINE CAME OUT WITH THE HANDLE BUT THE DEVICE DID NOT DEPLOY, IT REMAINED CONSTRAINED ON THE DELIVERY CATHETER. THE BACKUP HATCH WAS THEN ACCESSED AND THE PRIMARY STRING/DEPLOYMENT LINE WAS CONFIRMED TO NOT BE THERE. THE PHYSICIAN THEN CONTINUED ON WITH THE NORMAL DEPLOYMENT STEPS (NOT UTILIZING BACKUP HATCH) AND THE DEVICE DURING THIS TIME DID FULLY DEPLOY WITH GOOD RESULTS. THE PHYSICIAN REPORTS DEPLOYMENT WAS IN THE INTENDED LOCATION AND THERE WAS NO BREAKAGE OF THE PRIMARY DEPLOYMENT LINE, THE DEVICE JUST DID NOT DEPLOY CORRECTLY DURING PRIMARY DEPLOYMENT. THE PATIENT TOLERATED THE PROCEDURE. THE DELIVERY CATHETER, HANDLE AND DEPLOYMENT LINE WILL BE RETURNED TO GORE FOR EVALUATION.

  Patient problems: Aneurysm

  MAUDE report 21938461 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE REPORTED THE FOLLOWING: ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TO TREAT A THORACIC DISSECTION (IN DESCENDING THORACIC AORTA) WITH A HEMIARCH REPLACEMENT (IN ASCENDING THORACIC AORTA). THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2025, IMAGES REVEALED AN INNOMINATE ARTERY DISSECTION TO THE SUBCLAVIAN ARTERY AND CONTINUED FALSE LUMEN PROFUSION FROM PROXIMAL EDGE OF THE PREVIOUS IMPLANTED GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. UNDER FLUOROSCOPY THE PROXIMAL 1CM APPEARED CONSTRAINED, BUT IT HAD A DYNAMIC OBSTRUCTION THAT MOVED WITH THE HEARTBEAT. UNDER COMPUTED TOMOGRAPHY IT APPEARED CONSTRAINED BUT WAS NOT. THE PHYSICIAN REINTERVENED AND IMPLANTED A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TO BRIDGE AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE AORTIC COMPONENT AND SIDE BRANCH) IN THE LEFT COMMON CAROTID ARTERY. THE AREA WAS SEALED, AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 21701958 ↗
• InjuryDec 1, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE FOLLOWING WAS REPORTED ON 1/7/2024: IT WAS LATER REPORTED THAT THE FSA RECEIVED ADDITIONAL INFORMATION FROM THE PHYSICIAN ON (B)(6) 2024. PHYSICIAN REPORTED THAT ON (B)(6) 2024 PATIENT HAD PARALYSIS ON HIS HANDS AS WELL. A STROKE WAS ALSO OBSERVED. PHYSICIAN ALSO REPORTED PATIENT WAS SEEING A NEUROLOGIST. A CYST IN THE BRAIN WAS OBSERVED SOMETIME AFTER (B)(6) 2024. NEUROLOGIST REPORTS THE PARAPLEGIA AND QUADRIPLEGIA IS NOT RELATED TO THE GORE STENTS OR EVAR PROCEDURE. IT WAS REPORTED THE PARALYSIS AND STROKE PATIENT EXPERIENCED, WAS DUE TO AN INFECTION IN THE BRAIN THAT RAPIDLY PROGRESSED. ON (B)(6) 2024, PATIENT EXPIRED. PHYSICIAN REPORTS PARALYSIS, STROKE, AND DEATH IS NOT RELATED TO THE GORE DEVICES OR EVAR PROCEDURE AND IS DUE TO COMPLICATIONS FROM AN UNRELATED BRAIN INFECTION.

  Patient problems: Low Blood Pressure/ Hypotension; Paralysis

  MAUDE report 20814882 ↗
• InjuryApr 3, 2024Malposition of Device; Malposition of Device

  ON (B)(6) 2024, THE PATIENT UNDERWENT A FROZEN ELEPHANT TRUNK (FET) HYBRID OPEN PROCEDURE FOR TREATMENT OF A THORACIC AORTIC DISSECTION WITH COMPRESSED TRUE LUMEN USING ANTEGRADE PLACEMENT OF A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG A/C). THE GORE REPRESENTATIVE WAS NOT PRESENT AT THE CASE AND IT WAS NOTED THAT THE PHYSICIAN HAD PERFORMED THIS TYPE OF FET PROCEDURE MANY TIMES. IT WAS REPORTED THAT THE CTAG A/C DEVICE (TGMR313120) WAS DELIVERED SUCCESSFULLY OVER A GUIDEWIRE WITH THE PHYSICIAN STABILIZING THE DELIVERY CATHETER AND HANDLE AND ENSURING THE DEPLOYMENT LINES WERE STRAIGHT WHILE A FELLOW PERFORMED DEPLOYMENT. THE FIRST DEPLOYMENT STEPS WERE PERFORMED SUCCESSFULLY AND WITHOUT ISSUE, NO ANGULATION WAS PERFORMED, AND THE PHYSICIAN ATTEMPTED TO REMOVE THE LOCKWIRE. THE PHYSICIAN TURNED THE LOCKWIRE HANDLE 90 DEGREES AND PULLED, BUT REPORTEDLY EXPERIENCED HEAVY RESISTANCE. THE PHYSICIAN OPENED THE BACK-UP HATCH AND CUT AND PULLED THE LOCKWIRE. WHEN THE LOCKWIRE WAS PULLED THE PHYSICIAN AGAIN MET MUCH RESISTANCE NEAR WHAT WAS SUSPECTED TO BE THE LEADING OLIVE. THE LOCKWIRE WAS EVENTUALLY ABLE TO BE REMOVED. THE FINAL STAGE OF DEPLOYMENT WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19038199 ↗
• DeathOct 21, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2022 A PATIENT WAS ADMITTED FOR TEVAR OF A DISSECTION. AS REPORTED ON (B)(6) 2022, THE PATIENT PASSED. REPORTEDLY, THE CAUSE OF DEATH WAS DETERMINED TO BE RETROGRADE TYPE A DISSECTION. ACCORDING TO THE PHYSICIAN, THE PATIENT WAS SUFFERING FROM HYPERTENSION AND THAT MAY HAVE LED TO THE RETROGRADE DISSECTION. CONFIRMATION OF THE ORIGINAL GRAFT PLACEMENT AS WELL AS IF THE RETROGRADE DISSECTION ORIGINATED IMMEDIATELY ADJACENT TO THE PREVIOUSLY IMPLANTED DEVICE WAS REQUESTED. AS REPORTED THE PHYSICIAN COULD NOT CONFIRM THE EXACT LOCATION OF THE TEAR FOR THE RETROGRADE TYPE A DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 15649975 ↗
• InjuryDec 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE DEVICE): ON (B)(6) 2021, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM IN (ZONE 0) AND WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT HAD AN ACUTE ISCHEMIC STROKE. THE PATIENT REQUIRED PROLONGATION OF EXISTING HOSPITALIZATION AND DRUG THERAPY WAS INITIATED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 13098048 ↗
• MalfunctionNov 22, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE FSA REPORTED: ON (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE PATIENT WAS BEING TREATED WITH AN OPEN PROCEDURE AND FOR A RUPTURED TRANSVERSE ARCH DESCENDING THORACIC AORTA. REPORTEDLY THE PATIENT HAD A PREVIOUS PROCEDURE (DATE OF PROCEDURE IS UNKNOWN) WITH A HOMOGRAFT THAT WAS ALREADY IMPLANTED. DUE TO THE PATIENT STATUS, THERE WAS CPR BEING PERFORMED WHILE THE PHYSICIAN WAS ATTEMPTING TO WORK ON THE THORACIC AORTA RUPTURE. IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO INSERT THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM ANTEGRADE, WITH NO GUIDEWIRE AND NO FLUOROSCOPY. WHILE ATTEMPTING TO DEPLOY THE DEVICE, THE FIRST AND SECOND STEP WAS DONE SUCCESSFULLY. UPON ATTEMPTING TO RELEASE THE HANDLE, THE WIRE WAS NOT ATTACHED, AND THE DEVICE WAS NOT DEPLOYED BUT INSIDE THE PATIENT. THE PHYSICIAN REMOVED THE UNDEPLOYED DEVICE BY HAND. THE DEVICE WAS DESTROYED AT THE HOSPITAL. A DIFFERENT GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM DEVICE WAS USED AND DEPLOYED SUCCESSFULLY. THE PATIENT EXPIRED DURING THE PROCEDURE. THE CAUSE OF DEATH WAS NOT ATTRIBU

  Patient problems: Vascular Dissection

  MAUDE report 12853519 ↗
• MalfunctionNov 17, 2020Mechanical Problem; Mechanical Problem

  ON (B)(6) 2020, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ACUTE THORACIC AORTIC DISSECTION USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG-AC). IT WAS REPORTED THAT THE CTAG-AC DEVICE WAS INTRODUCED THROUGH A 20FR SHEATH AND PLACED IN THE DISTAL THORACIC AORTIC ARTERY ABOVE THE CELIAC ARTERY. WHEN THE PRIMARY DEPLOYMENT HANDLE WAS PULLED BACK, THE SUTURE BROKE, THE PHYSICIAN THEN ATTEMPTED TO UTILIZE THE BACK UP HATCH, LINE NUMBER ONE. THE DEPLOYMENT LINE SNAPPED/BROKE AGAIN. THE DEVICE WAS NOT DEPLOYED THROUGH THESE ATTEMPTS. THE DEVICE WAS REMOVED WITH THE DELIVERY CATHETER THROUGH THE SHEATH AND WILL BE RETURNED TO GORE FOR EVALUATION. A TWO DIFFERENT CTAG-AC DEVICE'S WERE USED FOR THE PROCEDURE. THERE WAS NO FURTHER ISSUES AND NO SERIOUS INJURY TO THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aortic Dissection

  MAUDE report 10856870 ↗
• InjuryAug 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019, THE PATIENT PRESENTED WITH A THORACOABDOMINAL AORTIC ANEURYSM (TAAA) CLASS II. A STAGED PROCEDURE WAS STARTED WITH THE IMPLANTATION OF TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM. ON THE SAME DATE THE PATIENT EXHIBITED LEFT LEG PARALYSIS. THE PATIENT WAS TREATED WITH A POST-OPERATIVE SPINAL DRAIN. IN-PATIENT PHYSICAL THERAPY IS CURRENTLY UNDER WAY AND THE PATIENT WILL BE DISCHARGED TO AN IN-PATIENT REHABILITATION CENTER.

  Patient problems: Paralysis

  MAUDE report 10451692 ↗
• DeathFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM ON (B)(6) 2020 FOR TREATMENT OF A THORACIC AORTIC ANEURYSM. A TRANSCAVAL ACCESS WAS UTILIZED, AND THE CTAG DEVICES WERE IMPLANTED WITHOUT ISSUE. AN ABBOTT PLUG WAS THEN IMPLANTED AT THE END OF THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE. AFTER THE PROCEDURE, THE PATIENT DEVELOPED THROMBUS IN THE SMA AND CELIAC ARTERIES. THROMBOLYTIC THERAPY WAS PERFORMED, BUT WAS INEFFECTIVE. THE PATIENT DIED ON (B)(6) 2020. THE PHYSICIAN IS UNSURE OF THE SOURCE OF THE THROMBUS, BUT DOES NOT BELIEVE IT IS DEVICE RELATED.

  Patient problems: Death; Thrombus

  MAUDE report 9757096 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P040043. One submission often covers many models, so check the product and lot details in each record.

• Z-0291-2021 · Sep 9, 2020 · Open, Classified
  GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
• Z-0290-2021 · Sep 9, 2020 · Open, Classified
  GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
• Z-2052-2020 · Dec 17, 2019 · Terminated
  Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
• Z-0048-2018 · Sep 25, 2017 · Terminated
  GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.
• Z-1236-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3410, 34mm x 10cm
• Z-1237-06 · Apr 28, 2006 · Terminated
  GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm